The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

Device Description

The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.

AI/ML Overview

The provided text describes the Z°Flex-270™ Steerable Sheath, a medical device, and its safety and substantial equivalence to a predicate device. This document is a 510(k) summary submitted to the FDA. It outlines the device's description, indications for use, and a comparison to a predicate device, focusing on technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present explicit "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it states that the device "met all specifications per functional and performance requirements" without detailing those specifications.

However, based on the performance (bench) testing listed, we can infer the categories of acceptance:

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Visual Assessment	Met specifications
Dimensional Accuracy	Met specifications
Functional: Hemostasis valve leak testing	Met specifications
Functional: Deflection testing	Met specifications
Functional: Air aspiration and hemostasis	Met specifications
Functional: Fatigue testing (deflection)	Met specifications
Sheath tip robustness after multiple deployment/retractions	Met specifications
Kink resistance	Met specifications
Torque	Met specifications
Tensile testing	Met specifications
Dilator to sheath retention	Met specifications
Guidewire testing	Met specifications
Biocompatibility
Cytotoxicity	Met specifications
Sensitization	Met specifications
Irritation/Intracutaneous Reactivity	Met specifications
Acute Systemic Toxicity	Met specifications
Materials Mediated Rabbit Pyrogen	Met specifications
Hemolysis	Met specifications
Partial Thromboplastin Time	Met specifications
Platelet and Leukocyte Counts	Met specifications
Complement Activation	Met specifications
Thrombosis (In-vivo) 4 hour contact	Met specifications
Testing for Latex, DEHP, and Bisphenol A	Met specifications
Sterilization	Met specifications
Shelf Life	Met specifications
Packaging	Met specifications

2. Sample size used for the test set and the data provenance:

Sample size: The document states that "representative finished, sterilized samples of the subject device underwent the following testing" but does not specify the exact number of samples used for any of the individual tests. This information is typically detailed in the full test reports, not usually in a 510(k) summary.
Data provenance: The testing performed is described as "Performance (bench) testing" and "biocompatibility testing." This indicates the data provenance is from laboratory bench testing and in-vitro/in-vivo animal studies (for biocompatibility), not human clinical trials. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are usually applicable to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to the described study. The study involves bench and biocompatibility testing of a medical device, not a diagnostic or AI device that requires expert interpretation to establish "ground truth." The "ground truth" for these tests would be the established scientific and engineering standards and methods against which the device's physical and biological properties are measured.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable to the described study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where multiple human readers or experts provide independent assessments, and a method is needed to resolve discrepancies. The provided document describes laboratory testing where results are typically objectively measured and compared against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable to the described study. An MRMC study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance. The Z°Flex-270™ Steerable Sheath is an interventional medical device, not a diagnostic AI system. The study described focuses on the device's physical and biological performance characteristics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable to the described study for the same reasons as above. This refers to the standalone performance of an AI algorithm, which is not what is being evaluated here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the mechanical performance tests, the "ground truth" (or reference) would be engineering specifications, industry standards (e.g., ISO 11070), and functional requirements defined by the manufacturer. These are objective, measurable criteria.
For the biocompatibility tests, the "ground truth" refers to established biological safety criteria and test methodologies (e.g., ISO 10993 series, though not explicitly cited beyond specific biological tests). The results are compared against acceptable levels of biological response.

8. The sample size for the training set:

This question is not applicable. The device is an interventional medical catheter, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process would involve internal testing and validation, but not in the sense of a machine learning training set.

9. How the ground truth for the training set was established:

This question is not applicable, as there is no training set for this type of medical device.

Summary

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<112541

Image /page/0/Picture/1 description: The image shows the logo for Greatbatch Medical. The logo consists of a hexagon shape with one of the hexagons filled in black. The text "Greatbatch Medical" is written to the right of the hexagon shape.

FEB - 7 2012

510(k) Summary

Applicant Information 1.0

Applicant:

Facility Establishment Registration Number:

Submitter:

Contact Person: Date Prepared:

Greatbatch Medical 2183787

Greatbatch Medical · 2300 Berkshire Lane North Minneapolis, MN 55441 (763) 951-8181 (Phone) (716) 759-5040 (Fax)

Sara Bakker August 31, 2011

2.0 Device Information

Trade Name: Common Name: Classification Name: Product Code: Regulation: Classification Panel:

Z°Flex-270™ Steerable Sheath Steerable Catheter Catheter, Steerable DRA Class II 21 CFR 870.1280 Cardiovascular

3.0 Predicate Device

The subject device is equivalent to the following device:

K102176 Medtronic FlexCath Steerable Sheath and Dilator .

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4.0 Description of Device

5.0 Indications for Use

The Z°Flex-270™ Steerable Sheath is indicated for use to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature and into the chambers of the heart.

6.0 Predicate Device Comparison / Technological Characteristics

The Z°Flex-270™ Steerable Sheath has similar indications for use, technological characteristics and identical principles of operation compared to the predicate Medtronic FlexCath Steerable Sheath (K102176). ZºFlex-270 indications for use differ from FlexCath in that Z°Flex-270 is intended for venous access only. Z°Flex-270 also differs slightly in the design of the deflection mechanisms and includes a guidewire, provided for convenience in the steerable sheath kit for convenience. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate device.

7.0 Description of Safety and Substantial Equivalence

To verify that the Z°Flex-270™ Steerable Sheath design met its functional and performance requirements, representative finished, sterilized samples of the subject device underwent the following testing, biocompatibility, sterilization, packaging, mechanical testing and shelf-life testing in accordance with applicable industry standards and FDA guidance.

Testing included:

Sterilization testing per ISO 11135-1 .
Shelf Life .
Packaging .
Performance (Bench) testing: .
- Visual
- Dimensional
- · Functional
  - . Hemostasis valve leak testing (per ISO 11070)
  - Deflection testing .
  - . Air aspiration and hemostasis
  - . Fatigue testing (deflection)

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Sheath tip robustness testing after multiple catheter . deployment/retractions
Kink resistance .
Torque .
Tensile testing .
Dilator to sheath retention .
Guidewire testing per ISO 11070 ●

Biocompatibility testing for the subject device included:

Cytotoxicity .
� Sensitization
Irritation/Intracutaneous Reactivity .
Acute Systemic Toxicity .
Materials Mediated Rabbit Pvrogen .
. Hemolysis
Partial Thromboplastin Time
. Platelet and Leukocyte Counts
. Complement Activation
Thrombosis (In-vivo) 4 hour contact .
Testing for Latex, DEHP, and Bisphenol A .

Conclusion: Test results demonstrate that the Z°Flex-270 Steerable Sheath met all specifications per functional and performance requirements. The device performs as intended and does not raise any new questions of safety or efficacy.

8.0 Statement of Equivalence

The Z°Flex-270 Steerable Sheath has similar indications for use, technological characteristics and identical principles of operation compared to the predicate Medtronic FlexCath Steerable Sheath. Based on these similarities, in addition to the results from safety and performance testing, ZºFlex-270 Steerable Sheath is considered substantially equivalent to the Medtronic FlexCath Steerable Sheath (K102176).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is the seal for the Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 7 2012

Greatbatch Medical c/o Ms. Sara Bakker Senior Regulatory Affairs Specialist 2300 Berkshire Lane N Minneapolis, MN 55441

Re: K112541

Trade Name: ZºFlex-270TM Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: II (two) Product Code: DRA Dated: November 30, 2011 Received: December 1, 2011

Dear Ms. Bakker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Sara Bakker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Indications for Use Statement

510(k) Number (if known):_K|| 254 l

Device Name: Z°Flex-2707M Steerable Sheath

Indications for Use:

The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K112541

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).